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Fraud and Compliance Forum 2022

Schedule

This program will be formatted as a traditional two and a half day in-person program - we are excited for attendees to connect and network in person. The program will begin on Wednesday, September 28 at 1:00 pm and end on Friday, September 30 at 12:45 pm. Visit the Continuing Education Information page for the number of credits available.

AHLA is committed to providing a safe and healthy environment for program participants and staff. AHLA has adopted preventative measures to reduce the potential spread of the COVID-19 virus, including proof of vaccine or a negative PCR test, and is following guidance provided by the US Centers for Disease Control and local authorities. Attendees are also expected to do their part and abide by AHLA’s Duty of Care.
 

Faculty Information

 

Schedule with Room Assignments

 


Wednesday, September 28, 2022

12:00-5:30 pm

Registration and Check-In
Come to AHLA Registration area to print out your badge. We'll need your proof of vaccine or negative PCR test on the Clear Health App.

 
1:00-2:45 pm

1. Billing and Coding Bootcamp
Robert Pelaia
Sean M. Weiss
Leonta (Lee) Williams

  The fundamentals of CPT and ICD-10-CM coding to include example exercises in the code selection process
  Hospital facility coding (ICD-10-PCS) and the inpatient prospective payment system (IPPS)
  Information detailing the process of resolving coding disputes, which commonly occur due to the lack of universal code selection standards and/or the failure to differentiate code selection from reimbursement rules
  Tips for evaluating weak spots in expert opinions w/ case examples will be provided

 
3:00-5:30 pm GENERAL SESSION

3:00-3:15 pm
Welcome and Introductions
Thomas Shorter, AHLA President
John Kelly, Program Planning Co-Chair
Albert Shay, Program Planning Co-Chair

3:15-4:15 pm
2. Enforcement Discussion
David S. Cade (Moderator)
Christi Grimm, Inspector General, OIG
Kenneth A. Polite, Assistant Attorney General, DOJ

4:30-5:30
3. Year in Review
Robert G. Homchick

This jam-packed session will cover key Fraud and Abuse developments over the past year. Highlights include:

  False Claims Act case law and settlements (record setting 2021 recoveries and enforcement trends)
  Stark and Anti-kickback developments
  The rise of telemedicine and its growing pains
  Reimbursement rollercoaster–340B, coding changes, new provider types
  COVID-related developments (the pandemic may be winding down but the related legal issues are not)
  Notable SCOTUS Rulings relating to fraud and reimbursement

 
5:30-6:30 pm
Networking Reception, sponsored by HealthCare Appraisers, Inc. 
This event is included in the program registration fee. Attendees, faculty, and registered guests are welcome.
 


Thursday, September 29, 2022

7:00 am-5:15 pm

Registration and Check-In
If you have not checked in, come to AHLA Registration area to print out your badge. We'll need your proof of vaccine or negative PCR test on the Clear Health App.

 
7:00-8:00 am
Continental Breakfast
This event is included in the program registration fee. attendees, faculty, and registered guests are welcome.
 
8:00-9:15 am | Extended Sessions

4. Physician Self-Referral (Stark) Bootcamp
(not repeated)
Mara Rendina
Joseph N. Wolfe

This session will provide an up to date basic overview of the Physician Self-Referral Law (Stark Law) and its implementing regulations, including the overall framework, interpretations, and potential areas of enforcement risk. Topics covered will include:

  • The Stark Law framework and its exceptions
  • Key definitions and interpretations, including compliance with the "Big 3"
  • The Value-Based framework
  • The Group Practice Rules
  • Auditing and monitoring considerations
  • Potential noncompliance and self-disclosures
 

5. False Claims Act Update
​(not repeated)
Robert S. Salcido
Benjamin C. Wei

  • Regarding FCA falsity, learn when, if ever, an opinion can be false or when reasonable disagreement can form the basis of an FCA action
  • As to FCA knowledge, learn latest court developments regarding whether reasonable interpretation of government rules can form the basis of an FCA violation when there is no official governmental guidance to warn the defendant away from its reasonable interpretation
  • In FCA / AKS litigation, learn the latest court decisions evaluating the extent to which plaintiff must show that the unlawful remuneration was the cause of the referral
  • As to FCA related COVID-19 and Pandemic Relief investigations and litigation, learn the latest enforcement trends
     

6. MD Anderson Cancer Center v. Office for Civil Rights, A Post-Decision Discussion of the MD Anderson appeal of a $4.3 million CMP and a Look at Current HIPAA Enforcement
Krista Barnes
Scott McBride

Over the past decade, the Office for Civil Rights has pursued millions of dollars in civil money penalty settlements from healthcare entities related to alleged violations of HIPAA standards. In 2017, the OCR proposed a $4.3 million CMP against MD Anderson Cancer Center for alleged disclosure and encryption violations. MD Anderson appealed the proposed CMP and after four years of litigation, the Fifth Circuit Court of Appeals vacated the entire CMP against MD Anderson. In a first of its kind decision, the Fifth Circuit rejected the OCR enforcement actions against MD Anderson and provided some needed comments regarding the OCR enforcement scheme.

This session is presented by MD Anderson and outside counsel involved in the appeal. In the session, we will review the factual background and how facts were portrayed in the stages of litigation. We will also review the administrative appeal process and issues that arose through that process. And we will walk through the Fifth Circuit decision and the arguments presented in the appeal by both MD Anderson and the OCR. Finally, we will look at how MD Anderson decision impacts ongoing enforcement and the current enforcement environment for HIPAA compliance. The specific bullet points to be covered are:

  • The factual background of MD Anderson and the administrative appeals process
  • The legal arguments made in MD Anderson by the parties and the Court’s opinion of first impression
  • Current HIPAA enforcement focus and use of the False Claims Act in cybersecurity compliance
 

7. Physician Compensation–The Enforcement Trend That Never Seems To Go Out Of Style
Michelle Frazier
Stacy Gerber Ward
Elizabeth Neiberg

  • Enforcement trends impacting physician compensation: How important is fair market value?
  • Fair market value: What it means and why it matters
  • How to determine fair market value: The three (3) well-known/recognized methodologies
  • Trends in physician compensation: From salaries to productivity-based compensation and back to salaries
  • Best practices in monitoring physician compensation
 
9:45-10:45 am

8. An Introduction to the Federal Anti-Kickback Statute and the Beneficiary Inducements Civil Monetary Penalty Law​
(not repeated)

Elizabeth Isbey
Stewart Kameen

  • Overview of the Federal Anti-Kickback Statute and the Beneficiary Inducements CMP
  • Key definitions, safe harbors, and exceptions
  • The framework for analyzing arrangements under these Federal fraud and abuse laws
  • Practical tips and strategies for compliance and for issue-spotting AKS/CMP issues in transactions
 

9. Privacy and Security Nuts and Bolts
(not repeated)

Nicholas Heesters
Alaap B. Shah

  • Who are covered entities and business associates under HIPAA
  • The Privacy, Security, and Breach Notification Rules
  • The Privacy Rule’s limits on uses and disclosures, individual privacy rights, and administrative requirements
  • The Security Rule’s requirements for administrative, physical, and technical safeguards
  • The Breach Notification Rule
  • HIPAA and COVID-19
  • HIPAA policy updates and recent enforcement actions
     

10. The DOJ and Corporate Compliance Programs–Historical Expectations and Recent Developments​
Adam Briggs
Salvador Hernandez
Jonathan Porter

This session highlights the compliance program expectations of the US Department of Justice (DOJ) as set out in the Evaluation of Corporate Compliance Programs (ECCP). Also covered will be the department’s 2021 white collar crime enforcement initiative and related compliance program enhancement initiative and their implications for the health care sector. 

  • The main elements of the ECCP and their applicability to the health care sector
  • A sample health care compliance program as measured against the expectations established under the ECCP  
  • The DOJ’s white collar crime enforcement initiative and takeaways for the health care sector one year on—including discussion of trends, key prosecutions, and settlements
  • Criminal- and civil-risk indicators and mitigation strategies in light of the DOJ enforcement initiative
  • Review of the DOJ’s compliance program enhancement initiative and analysis of related statements by DOJ leadership   
  • Development and implications of the DOJ’s requirement for “compliance officer certifications” in case-settlement agreements
 

11. Trending Anti-Kickback and Stark Law Issues Impacting Your Organization
Jacqueline Baratian
Tony Maida

  • Emerging AKS and Stark Law compliance issues and enforcement trends
  • How organizations are using the Sprint Rule value-based safe harbors and exceptions
  • How the Stark regulations have impacted physician contracting and compliance monitoring
 
10:45-11:15 am
Networking Coffee Break
Exhibits Open–Meet the Exhibitors
 
11:15 am-12:15 pm

12. False Claims Act Primer
(not repeated)

Kirk Ogrosky
Augustine M. Ripa

  • The elements of a False Claims Act violation
  • The consequences of a False Claims Act violation
  • What governmental agencies are involved in False Claims Act investigations
  • How DOJ investigates allegations of False Claims Act Violations
  • Industry Sectors most susceptible to False Claims Act scrutiny
  • False Claims Act trends, including recovery statistics and new matter statistics
 

13. Health System Acquisitions of Physician Practices: Navigating Compliance​
(not repeated)

Camella Boateng
Amy Hooper Kearby

  • The regulatory and enforcement environment
  • Understanding key risk areas for physician practice acquisitions
  • Best practices for managing compliance in physician practice acquisitions
  • Special considerations for the COVID-19 Public Health Emergency
     

14. Legal Ethics: The Dynamic Landscape of Legal and Compliance Roles
LaShon Kell
Matthew E. Wetzel

  • Compliance, Ethics & Integrity–As health lawyers and compliance officers, we talk extensively about “compliance & ethics” or “ethics & integrity” with respect to implementing corporate compliance programs. What does this mean from the Chief Compliance Officer’s viewpoint? How do two experienced CCOs view the concept of “ethics” in the context of building an effective compliance program? We will examine relevant government guidance and considerations (for example, DOJ’s compliance program evaluation criteria and OIG’s compliance program guidance) as well as assess current risks that compliance officers in the health care space might face when it comes to building an ethical “culture of compliance” 
  • Legal View–In addition, we will compare and contrast the obligations that in-house legal counsel might face that contract with compliance officers’ obligations. For many of us who are both compliance officers and lawyers, there is a “distinct and fuzzy line” between our roles, much of which hinges on the model rules of professional conduct for lawyers and the conflict that arises between these roles. In this segment of the presentation, we will analyze the various model rules of professional conduct as well as related guidance for health care compliance professionals
 

15. Defending–and Preventing–Stark and Anti-kickback Statute Issues in Hospital / Physician Transactions
Kim H. Looney
Michael E. Paulhus

Two experienced counsel who have handled the proactive compliance side, and back end investigation and FCA defense side, of multiple physician/hospital transactions, will grapple with the nuances of how Stark and AKS are applied to a physician transaction and what fact patterns cause real risk. These issues will be brought to life by audience participation and hypothetical discussions based on fact patterns in reported cases and settlements, including discussion on the following topics:

  • Exceptions and safe harbors–which ones really matter–and which ones typically don't
  • A conceptual framework to evaluate how Stark commercial reasonableness and the facts and circumstances analysis of AKS intent overlap
  • Whether a hospital can create pro formas accounting for future technical fees, yet not be considered to be purchasing referrals, and what about referral tracking?
  • The concept of "hopes and expectations" of referrals and actions that actually cross the line
  • What evidence of intent to purchase referrals is likely coming into evidence and other practical considerations in defending these cases
 
12:15-1:30 pm

Lunch on your own or attend the Networking and Presentation Lunch, Sponsored by BRG

CMS Program Integrity Priorities and Updates

Dara Corrigan
Deputy Administrator and Director of the Center for Program Integrity, CMS

Dara Corrigan, the Deputy Administrator and Director of the Center for Program Integrity (CPI), will provide an overview of the Center’s key priorities and how the Center is carrying out its mission of detecting and combatting fraud, waste, and abuse of the Medicare and Medicaid programs.

This event is not included in the program registration; there is an additional fee of $65; limited attendance; pre-registration required. Continuing Education Credits are not available for the lunch.

 
1:45-3:00 pm | Extended Sessions

16. Medicare Advantage/ Part C and D Primer
(not repeated)

Mandy Asgeirsson
Melissa Wong

Whether you are brand new to Medicare managed care or just need a refresher, this session will provide an overview of the basic structure and reimbursement mechanism of the Medicare Advantage/Part C and Medicare Part D programs, while focusing on key areas that are critical in addressing fraud, waste and abuse concerns.  Topics will include:

  • Medicare Parts C and D plan benefit design, required coverage and supplemental benefits, utilization management tools
  • Managed Medicare risk-sharing principles, including MA risk adjustment and Part D risk corridors, coverage gap and catastrophic coverage
  • Current trends and new developments in MA and Part D, including prescription drug provisions in the Inflation Reduction Act of 2022 
  • CMS audit areas and risks affecting MA and Part D, such as coding issues, improper sales and marketing practices
  • Things to know (and common misconceptions) about fraud and compliance in the MA and Part D space
 

17. MAC, OIG, or DOJ? The ABCs of Overpayments and Self-Disclosures
(not repeated)

David S. Schumacher (moderator)
Madeline Bainer
Miranda Hooker
Amanda Strachan

You've discovered a potential overpayment: Now what? The decision points for a health care provider can be confounding, and guidance is not always clear. The line between a good-faith billing dispute and a reckless false claim can be elusive. Government authorities regularly encourage providers to self-disclose, but disclose to whom? And what kind of "credit" is awarded for a self-disclosure? Join one of the most highly-decorated health care fraud prosecutors in the Department of Justice, an OIG attorney, and two fraud and abuse pros (both former DOJ health care fraud enforcers) for a lively, practical discussion regarding the self-disclosure landscape. This presentation will cover, among other topics:

  • Conducting internal investigations upon discovery of an overpayment
  • The 60-Day Rule and how do disclose overpayments to a MAC
  • How to determine if the OIG Self-Disclosure Protocol (SDP) is appropriate, and the ramifications and benefits of using the SDP
  • Pros and cons of using the SDP vs. disclosing directly to the DOJ
  • Recent OIG and DOJ guidance regarding DOJ review of self-disclosures
  • The benefits and risks of self-disclosures
     

18. Current State of Telehealth Enforcement
Karen S. Glassman
Laura F. Weidenfeld

  • Recent trends in use of telehealth by federal beneficiaries
  • Applicable state and federal requirements and restrictions on use of telehealth
  • Potential changes to federal telehealth requirements
  • Telehealth Special Fraud Alert
  • Recent developments in telehealth-related enforcement activity
 

7. Physician Compensation–The Enforcement Trend That Never Seems To Go Out Of Style
(repeat)

Michelle Frazier
Stacy Gerber Ward
Elizabeth Neiberg

  • Enforcement trends impacting physician compensation: How important is fair market value?
  • Fair market value: What it means and why it matters
  • How to determine fair market value: The three (3) well-known/recognized methodologies
  • Trends in physician compensation: From salaries to productivity-based compensation and back to salaries
  • Best practices in monitoring physician compensation
 
3:00-3:30 pm
Snack Break, sponsored by Pinnacle Healthcare Consulting
Exhibits Open–Meet the Exhibitors
 
 
3:30-4:30 pm

19. CIA Changes On The Horizon: What They Are And What They May Mean For You​ (Advanced)
(not repeated)

Laura Ellis
Mary Findley
Al Shay

This presentation will discuss changes OIG is planning to make to standard CIA provisions going forward and explain the reason for those changes. While these changes will directly affect those who enter into future CIAs with OIG, health care providers, compliance officers and counsel can learn from these CIA changes, even outside the context of a CIA, and consider proactive changes to compliance program policies to address OIG concerns. Issues to be discussed will include:

  • The role of the Compliance Officer and scope of responsibility
  • The changing role of the Compliance Committee and additional Compliance Committee responsibilities
  • Annual Risk Assessments and how they inform compliance program priorities and activities
  • Claims review, medical necessity determinations, and extrapolated overpayments
  • Creation of a CIA Transition Plan
 

20. Medicare Managed Care Enforcement Trends and Risk Areas
(not repeated)
John E. Kelly
Brian Martens
Megan Tinker

  • Enforcement trends involving Medicare Advantage and managed care
  • Key risk areas for managed care organizations and providers
  • Compliance program best practices to minimize risk
  • Audit focus areas and report takeaways from HHS-OIG
     

21. Sub-regulatory Guidance in Fraud and Compliance Actions
Lynn Adam
Daniel J. Hettich

Only a small fraction of HHS guidance is codified in regulations enacted through notice-and-comment rulemaking. HHS’s tens of thousands of pages of manual instructions are a testament to this fact. This session will discuss the role of sub-regulatory guidance in fraud and compliance actions and reimbursement disputes, including the latest views of the Biden administration and recent applications of the Supreme Court's 2019 decision in Azar v. Allina Health Services expanding the types of Medicare policies that must undergo notice-and-comment rulemaking to become effective. Topics will include:

  • What constitutes sub-regulatory guidance?
  • When does sub-regulatory guidance create a substantive legal standard under Allina?
  • Can sub-regulatory guidance trigger an “overpayment” and self-reporting obligations?
  • Is sub-regulatory guidance binding in False Claims Act litigation?
  • What are the implications of Allina for the “reasonable and necessary” standard, local coverage determinations (LCDs), and national coverage determinations (NCDs)?
 

22. Sweeping Under the Rug: Issues in Billing and Coding Diligence in M&A Transactions
Janice Jacobs
Ari J Markenson

  • How can a buyer complete effective billing and coding diligence when evaluating a seller’s business?
    • Why is sample size so important?
    • Challenges with obtaining documentation
    • How to Interpret audit results
  • What should (or must) a potential buyer do with the results of its billing and coding diligence?
    • If there are negative findings in an audit/review what legal risks are involved?
    • If there are negative findings in an audit/review how can the parties “put a box around” those risks in order to move forward with a potential transaction?
  • How do the results of billing and coding diligence get translated into the transaction documents?
 
4:45-5:15 pm

23. Contingency Management Rewards under the Beneficiary Inducement CMP (Advanced)
(not repeated)
Timothy P. Blanchard
Heather Westphal

  • Case study format
  • Evaluating potential CMP exceptions and safe harbors
  • Considering OIG advisory opinions
 

24. Nursing Homes: Where Do We Go From Here?
(not repeated)
Katie Arnholt
Vicki Robinson

The COVID-19 pandemic exacerbated longstanding problems with nursing home care. We are at an inflection point. Change to improve nursing home care must be grounded in clearsighted understanding of problems and root causes, and supported by government, the long-term care sector, and patient advocates. Improving nursing homes is OIG’s top priority. Two senior officials from OIG will discuss the following:  

  • OIG’s nursing home strategy
  • Oversight topics, including financing, staffing, and quality of care
  • Enforcement priorities
  • Quality of Care CIAs
     

25. Enforcement Trends in Clinical Labs
Anthony J. Burba
Andrea Treese Berlin

  • Updates/recent trends in fraud and enforcement for:
    • Toxicology testing
    • Genetic testing
    • COVID19 testing
  • Overview and discussion of:
    • Recent OIG Special Fraud Alert on telehealth
    • OIG laboratory-related priorities
    • Recent significant laboratory cases
 

26. EEK! The Government's Increased Use of EKRA (the Eliminating Kickbacks in Recovery Act) in Health Care Enforcement Actions
Kirti Vaidya Reddy

  • Background and summary of the SUPPORT Act’s Section 8122 - Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), and its far-reaching implications for laboratories, telehealth service providers, substance abuse providers, and COVID-19 health care providers
  • Comparison of EKRA and the Federal Anti-Kickback Statute and the False Claims Act
  • The increasing use of EKRA by the government and an examination cases in which the government has applied EKRA
  • Practical compliance tips and considerations to avoid potential violations of EKRA
 
5:15-6:15 pm
Networking Reception, sponsored by HealthCare Appraisers, Inc.
This event is included in the program registration. Attendees, faculty, and registered guests are welcome.

 


Friday, September 30, 2022

7:00-12:45 pm

Registration and Check-In
If you have not checked in, come to AHLA Registration area to print out your badge. We'll need your proof of vaccine or negative PCR test on the Clear Health App.

 
7:00-8:00 am
Continental Breakfast
This event is included in the program registration. Attendees, faculty, and registered guests are welcome.
 
8:00-9:15 am | Extended Sessions

27. Administrative Enforcement (CMS and OIG): Case Study​
(not repeated)

Greg Becker
Julie Burns
Judith A. Waltz

  • New authorities and focus for COVID-19 Fraud
  • CMS–Revocations of Enrollment, including under the “Affiliates” Rule, and Collateral Consequences
  • OIG–CMP Authorities, Exclusion, and the Role of the Fraud Risk Indicator
  • Appeals
  • No CMS policy issues will be discussed
 

28. Turn that Frown Upside Down: Finding Compliance with the Physician Self-Referral Law Instead of Violations
(not repeated)

William Mathias
Lisa Ohrin Wilson

….So you think you have a violation of the Physician Self-Referral Law and you have to make a disclosure?  Wait!  There may be a solution.  Learn practical ways to avoid SRDP disclosures. We will explore common problems like:

  • Can you ever really “cure” noncompliance with the physician self-referral law?
  • What to do when a physician uses too much space?
  • How to correct mistakes while an arrangement is still in place?
  • To what does the exception for isolated transactions actually apply now?
  • How to take advantage of the flexibility offered by “Reg Z”?
  • How and when should you claw back excess nonmonetary compensation?
     

6. MD Anderson Cancer Center v. Office for Civil Rights, A Post-Decision Discussion of the MD Anderson appeal of a $4.3 million CMP and a Look at Current HIPAA Enforcement
(repeat)

Krista Barnes
Scott McBride

Over the past decade, the Office for Civil Rights has pursued millions of dollars in civil money penalty settlements from healthcare entities related to alleged violations of HIPAA standards. In 2017, the OCR proposed a $4.3 million CMP against MD Anderson Cancer Center for alleged disclosure and encryption violations. MD Anderson appealed the proposed CMP and after four years of litigation, the Fifth Circuit Court of Appeals vacated the entire CMP against MD Anderson. In a first of its kind decision, the Fifth Circuit rejected the OCR enforcement actions against MD Anderson and provided some needed comments regarding the OCR enforcement scheme.

This session is presented by MD Anderson and outside counsel involved in the appeal. In the session, we will review the factual background and how facts were portrayed in the stages of litigation. We will also review the administrative appeal process and issues that arose through that process. And we will walk through the Fifth Circuit decision and the arguments presented in the appeal by both MD Anderson and the OCR. Finally, we will look at how MD Anderson decision impacts ongoing enforcement and the current enforcement environment for HIPAA compliance. The specific bullet points to be covered are:

  • The factual background of MD Anderson and the administrative appeals process
  • The legal arguments made in MD Anderson by the parties and the Court’s opinion of first impression
  • Current HIPAA enforcement focus and use of the False Claims Act in cybersecurity compliance
 

18. Current State of Telehealth Enforcement
(repeat)
Karen S. Glassman
Laura F. Weidenfeld

  • Recent trends in use of telehealth by federal beneficiaries
  • Applicable state and federal requirements and restrictions on use of telehealth
  • Potential changes to federal telehealth requirements
  • Telehealth Special Fraud Alert
  • Recent developments in telehealth-related enforcement activity
 

In-House Counsel Interactive Session
This session is limited to IN-HOUSE COUNSEL ATTENDEES ONLY and will be a moderated, open discussion about day to day issues. You must register in advance. The session is limited to 35 participants.

Moderators: Kristin C. Carter and Julie E. Kass

 Preparing for the End of the Public Health Emergency – Impacts on Telehealth and other Regulatory Flexibilities
 Addressing the Impact of Dobbs Decision
 Drawing Lines between Legal and Compliance? – Effective Coordination Between Essential Functions
 Best Practices for Advising on Fraud and Abuse Issues
 Conducting Internal Investigations – tips and best practices

 
9:45-10:45 am

29. Don’t Hide under the Desk when the Government Knocks: Tools to Prepare for CARES Act Audits and Enforcement Efforts
​(not repeated)

Jeffrey S. Cohen
Tynan Kugler
Jody Rudman

  • CARES Act enforcement efforts from lowest levels of fraud to more sophisticated investigations
  • OIG audit and investigative priorities
  • Criteria to have received and spent governmental funds in the context of an audit
  • How to prepare, how to respond, and what possible outcomes to expect from an audit
 

22. Sweeping Under the Rug: Issues in Billing and Coding Diligence in M&A Transactions
(repeat)

Janice Jacobs
Ari J Markenson

  • How can a buyer complete effective billing and coding diligence when evaluating a seller’s business?
    • Why is sample size so important?
    • Challenges with obtaining documentation
    • How to Interpret audit results
  • What should (or must) a potential buyer do with the results of its billing and coding diligence?
    • If there are negative findings in an audit/review what legal risks are involved?
    • If there are negative findings in an audit/review how can the parties “put a box around” those risks in order to move forward with a potential transaction?
  • How do the results of billing and coding diligence get translated into the transaction documents?
     

15. Defending–and Preventing–Stark and Anti-kickback Statute Issues in Hospital / Physician Transactions
(repeat)

Kim H. Looney
Michael E. Paulhus

Two experienced counsel who have handled the proactive compliance side, and back end investigation and FCA defense side, of multiple physician/hospital transactions, will grapple with the nuances of how Stark and AKS are applied to a physician transaction and what fact patterns cause real risk. These issues will be brought to life by audience participation and hypothetical discussions based on fact patterns in reported cases and settlements, including discussion on the following topics:

  • Exceptions and safe harbors–which ones really matter–and which ones typically don't
  • A conceptual framework to evaluate how Stark commercial reasonableness and the facts and circumstances analysis of AKS intent overlap
  • Whether a hospital can create pro formas accounting for future technical fees, yet not be considered to be purchasing referrals, and what about referral tracking?
  • The concept of "hopes and expectations" of referrals and actions that actually cross the line
  • What evidence of intent to purchase referrals is likely coming into evidence and other practical considerations in defending these cases
 

21. Sub-regulatory Guidance in Fraud and Compliance Actions
(repeat)

Lynn Adam
​Daniel J. Hettich

Only a small fraction of HHS guidance is codified in regulations enacted through notice-and-comment rulemaking. HHS’s tens of thousands of pages of manual instructions are a testament to this fact. This session will discuss the role of sub-regulatory guidance in fraud and compliance actions and reimbursement disputes, including the latest views of the Biden administration and recent applications of the Supreme Court's 2019 decision in Azar v. Allina Health Services expanding the types of Medicare policies that must undergo notice-and-comment rulemaking to become effective. Topics will include:

  • What constitutes sub-regulatory guidance?
  • When does sub-regulatory guidance create a substantive legal standard under Allina?
  • Can sub-regulatory guidance trigger an “overpayment” and self-reporting obligations?
  • Is sub-regulatory guidance binding in False Claims Act litigation?
  • What are the implications of Allina for the “reasonable and necessary” standard, local coverage determinations (LCDs), and national coverage determinations (NCDs)?
 

9:30-10:45 am
Compliance Officer Interactive Session

This session is limited to COMPLIANCE OFFICER ATTENDEES ONLY and will be a moderated, open discussion about day to day issues. You must register in advance. The session is limited to 35 participants.

Some of the topics may include:

  No Surprises Act and Hospital Price Transparency – How are compliance officers playing a role in this regulatory initiative?
  Evaluating the effectiveness of a compliance Program – Share tips and best practices
  Operationalizing the compliance program in your setting – Hospital, Medical Practice, Labs, ASC, etc.
  Conducting compliance screenings on employee and providers

Moderators: Ami Sparano and Adam Briggs

 
11:00 am-12:00 pm

30. To Infinity and Beyond: Coordinating Incident Response Obligations–HIPAA, State Law, International Law, and Beyond
(not repeated)

Marti Arvin
Joseph A. Dickinson

  • Regulatory–Is it clear what laws and regulations apply to the data that was compromised, common themes, hidden pitfalls
  • Contractual terms–What are they, who looks at them, where are they all hidden?
  • Policy–Legacy data risk, what has the organization acquired, how is it retained, how is it destroyed?
 

10. The DOJ and Corporate Compliance Programs–Historical Expectations and Recent Developments​
(repeat)

Adam Briggs
Salvador Hernandez
Jonathan Porter

This session highlights the compliance program expectations of the US Department of Justice (DOJ) as set out in the Evaluation of Corporate Compliance Programs (ECCP). Also covered will be the department’s 2021 white collar crime enforcement initiative and related compliance program enhancement initiative and their implications for the health care sector. 

  • The main elements of the ECCP and their applicability to the health care sector
  • A sample health care compliance program as measured against the expectations established under the ECCP  
  • The DOJ’s white collar crime enforcement initiative and takeaways for the health care sector one year on—including discussion of trends, key prosecutions, and settlements
  • Criminal- and civil-risk indicators and mitigation strategies in light of the DOJ enforcement initiative
  • Review of the DOJ’s compliance program enhancement initiative and analysis of related statements by DOJ leadership   
  • Development and implications of the DOJ’s requirement for “compliance officer certifications” in case-settlement agreements
     

11. Trending Anti-Kickback and Stark Law Issues Impacting Your Organization
(repeat)

Jacqueline Baratian
Tony Maida

  • Emerging AKS and Stark Law compliance issues and enforcement trends
  • How organizations are using the Sprint Rule value-based safe harbors and exceptions
  • How the Stark regulations have impacted physician contracting and compliance monitoring
 

14. Legal Ethics: The Dynamic Landscape of Legal and Compliance Roles​
​(repeat)

LaShon Kell
Matthew E. Wetzel

  • Compliance, Ethics & Integrity–As health lawyers and compliance officers, we talk extensively about “compliance & ethics” or “ethics & integrity” with respect to implementing corporate compliance programs. What does this mean from the Chief Compliance Officer’s viewpoint? How do two experienced CCOs view the concept of “ethics” in the context of building an effective compliance program? We will examine relevant government guidance and considerations (for example, DOJ’s compliance program evaluation criteria and OIG’s compliance program guidance) as well as assess current risks that compliance officers in the health care space might face when it comes to building an ethical “culture of compliance” 
  • Legal View–In addition, we will compare and contrast the obligations that in-house legal counsel might face that contract with compliance officers’ obligations. For many of us who are both compliance officers and lawyers, there is a “distinct and fuzzy line” between our roles, much of which hinges on the model rules of professional conduct for lawyers and the conflict that arises between these roles. In this segment of the presentation, we will analyze the various model rules of professional conduct as well as related guidance for health care compliance professionals
 
12:15-12:45 pm

31. False Claims Act Allegations Based on Statistical Sampling and Extrapolation
(not repeated)

Christopher C. Sabis
Chris Terranova

  • The basics of statistical sampling in FCA cases
  • Recent case law on the use of statistical sampling and extrapolation in FCA cases
  • The pros and cons of statistical sampling
  • Using statistical sampling to value and resolve FCA cases
 

32. 340B Compliance
(not repeated)

Barbara S. Williams

  • Focus on latest developments in 340B compliance issues
  • The Genesis case and impact on 340B patient definition guidance
  • Changes in HRSA audit scope for patient definition and duplicate discounts
  • What to expect with HRSA enforcement activity
     

25. Enforcement Trends in Clinical Labs
(repeat)

Anthony J. Burba
Andrea Treese Berlin

  • Updates/recent trends in fraud and enforcement for:
    • Toxicology testing
    • Genetic testing
    • COVID19 testing
  • Overview and discussion of:
    • Recent OIG Special Fraud Alert on telehealth
    • OIG laboratory-related priorities
    • Recent significant laboratory cases
 

26. EEK! The Government's Increased Use of EKRA (the Eliminating Kickbacks in Recovery Act) in Health Care Enforcement Actions
(repeat)

Kirti Vaidya Reddy

  • Background and summary of the SUPPORT Act’s Section 8122 - Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), and its far-reaching implications for laboratories, telehealth service providers, substance abuse providers, and COVID-19 health care providers
  • Comparison of EKRA and the Federal Anti-Kickback Statute and the False Claims Act
  • The increasing use of EKRA by the government and an examination cases in which the government has applied EKRA
  • Practical compliance tips and considerations to avoid potential violations of EKRA

In-Person Program Format

How It Works

  • We will offer in-depth breakout sessions where speakers and attendees can interact and collaborate with each other in-person.
  • We consider the health and safety of all those onsite at in-person programs our top priority. AHLA will follow guidance and requirements issued by the CDC as well as by state and local government.. 
  • All attendees, who register for the in-person program, will be required to commit to our Duty of Care agreeing to follow the protocols we establish and monitor their own health for the health and safety of all. 
  • We have adopted a new onsite registration system by providing seamless check-in, onsite badge printing, and safety supplies to all attendees to use while in attendance.
  • Built-in extended time between sessions for moving from room to room, networking with colleagues, and personal break time.  
  • Socially distanced seating arrangements in breakout rooms, regular cleaning in and around meeting spaces, and appropriate signage/floor decals to reinforce spatial distancing and other safety reminders.
  • All program sessions will be recorded. Video of the presentations, along with the materials will be available to all attendees who register to apply for additional On Demand Continuing Education Credits. Those that cannot attend in-person can purchase the eProgram and apply for Continuing Education Credits. More information on our ePrograms.

Benefits of the In-Person Program

  • Step out from behind your computer and network face-to-face with other health law professionals.
  • Interact with colleagues at in-depth breakout sessions.
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